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Ibuprofen and Pseudoephedrine HCl

Medically reviewed on Dec 7, 2017

Dosage form: capsule, liquid filled
Ingredients: IBUPROFEN 200mg, PSEUDOEPHEDRINE HYDROCHLORIDE 30mg
Labeler: Aurohealth LLC
NDC Code: 58602-803

Ibuprofen and Pseudoephedrine HCl Capsules 200 mg/30 mg

Drug Facts

Active ingredients (in each liquid-filled capsule)

Solubilized ibuprofen equal to 200 mg ibuprofen USP (NSAID)*
(present as the free acid and potassium salt)
Pseudoephedrine Hydrochloride USP 30 mg
*nonsteroidal anti-inflammatory drug

Purposes

Pain reliever/fever reducer
Nasal decongestant

Uses

temporarily relieves these symptoms associated with the common cold or flu:

  • headache
  • sinus pressure
  • nasal congestion
  • minor body aches and pains
  • fever

Warnings

Allergy alert: Ibuprofen may cause a severe allergic reaction, especially in people allergic to aspirin.

Symptoms may include:

  • hives
  • facial swelling
  • asthma (wheezing)
  • shock
  • skin reddening
  • rash
  • blisters

If an allergic reaction occurs, stop use and seek medical help right away.

Stomach bleeding warning:
This product contains an NSAID, which may cause severe stomach bleeding. The chance is higher if you:

  • are age 60 or older
  • have had stomach ulcers or bleeding problems
  • take a blood thinning (anticoagulant) or steroid drug
  • take other drugs containing prescription or nonprescription NSAIDs [aspirin, ibuprofen, naproxen, or others]
  • have 3 or more alcoholic drinks every day while using this product
  • take more or for a longer time than directed

Heart attack and stroke warning

NSAIDs, except aspirin, increase the risk of heart attack, heart failure, and stroke. These can be fatal. The risk is higher if you use more than directed or for longer than directed.


Do not use
  • in children under 12 years of age
  • if you have ever had an allergic reaction to any other pain reliever/fever reducer
  • right before or after heart surgery
  • if you are now taking a prescription monoamine oxidase inhibitor (MAOI) (certain drugs for depression, psychiatric, or emotional conditions, or Parkinson’s disease), or for 2 weeks after stopping the MAOI drug. If you do not know if your prescription drug contains an MAOI, ask a doctor or pharmacist before taking this product.

Ask a doctor before use if
  • stomach bleeding warning applies to you
  • you have problems or serious side effects from taking pain relievers or fever reducers
  • you have a history of stomach problems, such as heartburn
  • you have high blood pressure, heart disease, liver cirrhosis, kidney disease, asthma, thyroid disease, diabetes, have trouble urinating due to an enlarged prostate gland, or had a stroke
  • you are taking a diuretic

Ask a doctor or pharmacist before use if you are
  • under a doctor’s care for any serious condition
  • taking any other product that contains pseudoephedrine or any other nasal decongestant
  • taking aspirin for heart attack or stroke, because ibuprofen may decrease this benefit of aspirin
  • taking any other drug

When using this product
  • take with food or milk if stomach upset occurs

Stop use and ask a doctor if
  • you experience any of the following signs of stomach bleeding:
    • feel faint
    • vomit blood
    • have bloody or black stools
    • have stomach pain that does not get better

  • you have symptoms of heart problems or stroke:
    • chest pain
    • trouble breathing
    • weakness in one part or side of body
    • slurred speech
    •  leg swelling 

  • fever gets worse or lasts more than 3 days
  •  nasal congestion lasts for more than 7 days
  • symptoms continue or get worse
  • redness or swelling is present in the painful area
  • you get nervous, dizzy, or sleepless
  • any new symptoms appear 

If pregnant or breast-feeding,

ask a health professional before use. It is especially important not to use ibuprofen during the last 3 months of pregnancy unless definitely directed to do so by a doctor because it may cause problems in the unborn child or complications during delivery.

Keep out of reach of children.

In case of overdose, get medical help or contact a Poison Control Center (1-800-222-1222) right away.

Directions

●   do not take more than directed
●   the smallest effective dose should be used
●   adults and children 12 years of age and over:
        ●   take 1 capsule every 4 to 6 hours while symptoms persist. If symptoms do not respond to 1 capsule, 2 capsules may be used.
        ●   do not use more than 6 capsules in any 24-hour period unless directed by a doctor
●   children under 12 years of age: do not use
 

Other information

  • each capsule contains: potassium 20 mg
  • store at 20° to 25°C (68° to 77°F). Avoid excessive heat above 40°C (104°F).
  • read all warnings and directions before use. Keep carton.

Inactive ingredients

Black iron oxide, D&C yellow no. 10, gelatin, hypromellose, neelicert FD&C red no. 40, polyethylene glycol, potassium hydroxide, propylene glycol, sorbitol sorbitan solution.

Questions or comments?
call 1-855-274-4122

Distributed by:
AUROHEALTH LLC
2572 Brunswick Pike
Lawrenceville, NJ 08648

Made in India
Code:TS/DRUGS/22/2009

PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 200 mg/30 mg (20 Liquid-Filled Capsules)

AUROHEALTH

NDC 58602-803-67


*Compare to the active
Ingredients of Advil Cold &Sinus

Non-Drowsy
COLD & SINUS RELIEF

Ibuprofen and Pseudoephedrine HCl Capsules

200 mg/30 mg

Ibuprofen 200 mg - Pain Reliever/Fever Reducer (NSAID)
Pseudoephedrine HCl 30 mg - Nasal Decongestant

  • Relieves Sinus Pressure
  • Nasal Congestion and Fever

20 Liquid-Filled Capsules
(2 X 10 capsules per blister card)


IBUPROFEN AND PSEUDOEPHEDRINE HCL 
ibuprofen and pseudoephedrine hcl capsule, liquid filled
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:58602-803
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
IBUPROFEN (IBUPROFEN) IBUPROFEN200 mg
PSEUDOEPHEDRINE HYDROCHLORIDE (PSEUDOEPHEDRINE) PSEUDOEPHEDRINE HYDROCHLORIDE30 mg
Inactive Ingredients
Ingredient NameStrength
FERROSOFERRIC OXIDE 
D&C YELLOW NO. 10 
GELATIN, UNSPECIFIED 
HYPROMELLOSE 2910 (6 MPA.S) 
FD&C RED NO. 40 
POLYETHYLENE GLYCOL 600 
POTASSIUM HYDROXIDE 
PROPYLENE GLYCOL 
SORBITOL 
Product Characteristics
ColorORANGE (Light Orange to Light Yellow with a Slight Orange hue) Scoreno score
ShapeOVALSize15mm
FlavorImprint CodeIBP200
Contains    
Packaging
#Item CodePackage Description
1NDC:58602-803-672 BLISTER PACK in 1 CARTON
1NDC:58602-803-8310 CAPSULE, LIQUID FILLED in 1 BLISTER PACK
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA20923512/01/2017
Labeler - Aurohealth LLC (078728447)
Establishment
NameAddressID/FEIOperations
Aurobindo Pharma Limited650381903ANALYSIS(58602-803), MANUFACTURE(58602-803)
Establishment
NameAddressID/FEIOperations
Embio Limited916512449API MANUFACTURE(58602-803)
Establishment
NameAddressID/FEIOperations
IOL Chemicals and Pharmaceuticals Limited677605646API MANUFACTURE(58602-803)

 
Aurohealth LLC

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

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